COMING TO AHEAD
New drugs in development may offer serious relief from migraines
“THERE ARE A LOT OF PATIENTS OUT THERE THAT HAVE ALREADY TRIED EVERYTHING WE HAVE.” DR. ATHENA KOSTIDIS, Loyola University Medicine neurologist who specializes in migraines
More likely than not, you know someone who has had a migraine, one of those blindingly painful headaches that can come with sensitivity to light and sound or nausea.
Maybe you’ve had one, or many, eating up whole days at a time while you recover in a darkened room.
They’re so common— impacting more than 14 percent of the adult population in the last three months, according to recent data. But scientists have made few advancements in the way migraines are treated over the years, leaving some chronic sufferers unable to find relief.
That could change soon, as a group of new drugs in development have recently shown promising results in studies done before U. S. Food and Drug Administration review. These drugs, which target a specific group of amino acids in the brain, are the first ever developed to specifically treat migraines.
“It has an enormous potential to change the lives of headache patients,” said Dr. Rebecca Burch, a board certified headache specialist at the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston.
The drugs work by blocking the brain’s reception of a specific group of amino acids called the Calcitonin Gene- Related Peptides, which are believed to dilate blood vessels in the brain, contributing to the development of a migraine. There are at least four injectible drugs in development that inhibit the CGRP receptor in the brain, and each has made strides towards FDA review in recent months.
Amgen, Eli Lilly& Co., Teva Pharmaceutical Industries and Alder Biopharmaceuticals each have a Calcitonin GeneRelated Peptide product in the works. So far, only Amgen has submitted an application for approval to the FDA, but the remainder are expected to follow this year or next, according to the companies.
The current schedule could see one of the drugs on the market by next year, according to Dr. David Dodick, a neurologist who leads the Mayo Clinic’s Headache Program.
Study participants saw a significant a decrease in days spent dealing with a migraine, Dodick said.
The drugs would be used as a preventative measure for people who suffer from chronic migraines, which typically means about four times or more a month, Burch said. These people can’t simply treat their migraines as they get them, because many drugs meant to treat the pain on the spot actually exacerbate the headaches over time, she added.
“There are a lot of patients out there that have already tried everything we have,” said Dr. Athena Kostidis, a Loyola University Medicine neurologist who specializes in migraines.
The hope is to give those patients their life back, Kostidis said.
Currently, the only preventative drugs available to migraine sufferers are medications originally developed to treat other things— like seizures, depression and high blood pressure— that were found to impact migraines as well. These drugs can come with serious risks and side effects, leaving migraine sufferers to weigh whether pain relief is worth the extra baggage.
But other than some irritation at the injection site, the studies of the new drugs haven’t reported any notable side effects. This is in part because the drugs were actually developed for migraines, so there are fewer unwanted effects, Dodick said.
The lack of serious side effects observed in the studies so far checks another box on neurologists’ wish list for migraine treatments.
“The holy grail of preventive medication is something that is effective, that works quickly and that has few side effects, and certainly we don’t have a lot of treatments that meet that criteria right now,” Burch said.
The excitement around these new products among doctors is tempered a little bit by concerns about as- yet unseen side effects and the cost of treatment.
The injections are likely going to be very expensive, which could limit patients’ access, said Burch. Insurers may want patients to try several other treatments before they get a chance at these drugs, she added.
And the function of the protein the drugs block does raise a theoretical concern about cardiovascular effects, Dodick said.
“One of the things it does is dilate blood vessels, and that may be particularly important when a blood vessel is blocked, as occurs in patients who are having a stroke,” Dodick said. “You could be potentially blocking the body’s ability to dilate a blood vessel when it’s needed.”
But there’s been no evidence of this problem in the clinical trials, Dodick said, and there are many other proteins in the body that dilate blood vessels.
Despite the unknowns, the development of these drugs means scientists know more about treating migraines than ever before, and that knowledge will build on itself, Dodick said. People whose migraines do not respond to these drugs— or any others on the market— may get their solution in another drug developed in this vein, he said.
For now, Dodick said he is excited about the idea of treating migraine sufferers with a drug developed just for them.
“That is an exciting day,” he said. “I think this is just the beginning.”